NCT04759573: EVC

Effects of Early Vocal Contact (EVC) in the Neonatal Intensive Care Unit

Status unknown NA Last updated 18 February 2021

What this trial tests

NA trial testing Early Vocal Contact in Early Intervention in 80 participants. Status unknown.

Timeline

1 February 2019

Primary endpoint
1 June 2022

1 June 2024

Quick facts

Lead sponsor	Elisa Della Casa Muttini
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	80
Start date	1 February 2019
Primary completion	1 June 2022
Estimated completion	1 June 2024
Sites	1 location across Italy

Drugs / interventions tested

• Early Vocal Contact
• Behavioral Observation

Conditions studied

• Early Intervention — all drugs for Early Intervention →
• Prematurity — all drugs for Prematurity →

Sponsor

Elisa Della Casa Muttini

Who can join

Adults 25 Weeks to 33 Weeks, any sex, with Early Intervention or Prematurity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Preterm infants are at risk for developing altered trajectories of cognitive, social, and linguistic competences compared to a term population. This is mainly due to medical and environmental factors, as they are exposed to an atypical auditory environment and, simultaneously, to long periods of early separation from their parents. The short-term effects of Early Vocal Contact (EVC) on an infant's early stability have been investigated, but currently, there is limited evidence of its impact on the infant's autonomic nervous system maturation, as indexed by the heart rate variability, as well as on its long-term impact on infant neurodevelopment. This multi-centric study aims to investigate the effects of EVC on a preterm infant's physiology, neurobehaviour, and development.

Methods: Eighty stable preterm infants, born at 25 to 32 weeks and 6 days gestational age, without specific abnormalities, will be selected and randomized to either an intervention or a control group. The intervention group will receive EVC: mothers talking and singing to their preterm infants for 10 minutes thrice a week for 2 weeks. Mothers in the control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviour through a standard cluster of indicators. Infants will be assessed at baseline, at the end of the intervention, at term equivalent age, and at 3, 6, 12- and 24-months corrected age, with a battery of physiological, neurobehavioral, and developmental measures.

Discussion: Early interventions in the neonatal intensive care unit have shown important effects on the neurodevelopment of preterm infants, lowering the negative long-term effects of an atypical auditory and interactional environment. This study will provide new insights into the mother-infant early contact as protective intervention against the sequelae of prematurity during the sensitive period of development. An early intervention, such as EVC, is intuitive and easy to implement in the daily care of preterm infants. However, its long-term effects on infant neurodevelopment and on maternal sensitivity and stress still need accurate investigations.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Musical and vocal interventions to improve neurodevelopmental outcomes for preterm infants.
   Haslbeck FB, Mueller K, Karen T, Loewy J, et al · · 2023 · cited 24× · PMID 37675934 · DOI 10.1002/14651858.cd013472.pub2
2. Maternal singing sustains preterm hospitalized newborns' autonomic nervous system maturation: an RCT.
   Filippa M, Nardelli M, Sansavini A, Meloni S, et al · · 2024 · cited 9× · PMID 38057574 · DOI 10.1038/s41390-023-02932-4
3. Effects of Early Vocal Contact in the Neonatal Intensive Care Unit: Study Protocol for a Multi-Centre, Randomised Clinical Trial.
   Filippa M, Della Casa E, D'amico R, Picciolini O, et al · · 2021 · cited 7× · PMID 33917889 · DOI 10.3390/ijerph18083915